FDA recall D-1049-2020

Grato Holdings, Inc. · Class III · drug

Product

Colostat, Homeopathic Remedy, 1 fl. oz. (30 mL) per bottle, 20% Ethanol, Dist. by Energique, Inc., 201 Apple Blvd., Woodbine, IA 51579, NDC 44911-0411-1

Reason for recall

Labeling mix-up - Indications on product label are incorrect.

Distribution

U.S.A. Nationwide, Israel

Key facts

Status
Terminated
Initiation date
2019-11-15
Report date
2020-04-01
Termination date
2020-09-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Woodbine, IA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1049-2020